Methods to arrest cancer cell growth and proliferation using electromagnetic energy delivered via electromagnetic coil systems

ABSTRACT

A non-invasive method of using electromagnetic field energies to reduce or arrest the growth rate and proliferation of cancer cells, and induce apoptosis in cancer cells, and reduce or arrest the growth and survival of foreign pathogens, relatively without significantly harming normal cells beyond their physiologic threshold of survival are provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/484,729, filed Jun. 15, 2009, which claims the benefit ofU.S. Provisional Patent Application Ser. No. 61/129,749, filed Jul. 16,2008, the entire disclosures of which are hereby incorporated herein byreference.

FIELD OF INVENTION

The present invention is generally related to treatments usingelectromagnetic energy.

BACKGROUND

Electric fields of endogenous origin have been measured outside theperiphery of cultured cells, within multiple tissues and cell types ofdeveloping embryos, and at the borders of healing and regeneratingtissues. Electrically charged and charge-dependent molecules of cellsand tissues are naturally inherent to biologic systems and assist indefining their electro-physiologic and functional properties, therebypermitting them to self-regulate and interact with their associatedmolecules and related biologic systems. At the molecular level of allcells, tissues and organs, the physiologic and biochemical processesdirecting cell survival, growth and proliferation function such asprogrammed cell death requires a complex series of fundamentalalterations and modifications in the electrostatic bonding interactionswithin their given bio-regulatory systems. These charge-dependent cellgoverning bio-regulatory systems are in fact naturally inherent withinall living cells, tissues and organisms. Certain exogenously appliedelectromagnetic fields of low energy have been demonstrated to altercell membrane signaling systems, cell membrane potentials,oxidative/reductive processes and rates, DNA transcription,thermodynamic and kinetic driven protein folding, ion drift andcollision rates, immune cell activity and response, and enzymemodulation when applied to a wide variety of biologic systems.

Making use of these phenomena, electromagnetic fields of low energy havebeen used therapeutically for several years or more to stimulate bonegrowth and repair, as well as healing and regeneration of other varioustissues in humans and animals.

SUMMARY

In the context of cancer therapeutics, there are physiologic differencesbetween normal cells and cancer cells which render the cancer cells withdifferent sensitivity than normal healthy cells to the electromagneticfield applications described herein.

In another biologically-linked context, infections within the bodycavity and tissues of body organs stemming from the presence of foreignpathogens such as virus, bacteria, fungi and parasites have beenwell-defined and established in many clinical cases as causative factorsrelated to the initiation and progression of many cancer types. Thisprocess typically occurs via infection-induced inflammatory processesthat eventually progress into a physio-pathologic disorder throughcascades of bio-molecular interactions of toxic metabolic by-productswith healthy cells and tissues, and or cancer-inducing processessecondary to genome modification and mutation of healthy cells via viralintegration into the host genome. Important as it is to therapeuticallyarrest cancer cell growth and proliferation, it is equally as importantto address the growth and proliferation of foreign pathogens which canin fact be either present and directly causative to the cancer conditionbeing treated, or can potentially be a cancer-causative factor via thephysiologic and biochemical stress these foreign pathogens place uponhealthy cells and tissues. Since foreign pathogens typically differ fromnormal cells and cancer cell types in properties such as biochemical,biophysical, genetic and phenotypic, it is expected that the sensitivityof these foreign pathogens to applied electromagnetic field signals willdiffer from that of both normal and cancer cells and tissues.

The methods and applications described for electromagnetic fieldinductive coupling to cancer cells, cancerous tumor tissues and/orforeign pathogens are utilized to adversely affect the cancer cellsand/or foreign pathogen bio-regulatory growth, proliferation andsurvival systems without harming, beyond a physiologic lethal tolerance,the bio-regulatory growth, proliferation and survival systems ofsurrounding non-pathologic normal cells and tissues. That is to say,embodiments of the present invention are directed specifically towardadversely altering the bio-regulatory electrical energies of cancercells and/or foreign pathogens, more specifically, the bio-regulatoryelectrical energies that are involved in the physiologic processes ofcancer cell and/or foreign pathogen growth, proliferation, and survival.

Embodiments of the present invention accomplish this without lethallyaffecting the bio-regulatory systems of normal cells and tissues.

Methods are provided for introducing exogenously applied electromagneticfield energy of specific signal parameters into a biological system ofcancer cells, cancerous tumor tissues and/or foreign pathogens. Thisprovides the ability to induce growth arrest and apoptotic cell death incancer cells and cancerous tumors, and adversely affect the growth andsurvival capability of foreign pathogens, via the electromagneticfield's energy affect upon the bio-regulatory electric energies of thatcancerous and/or foreign pathogenic system being treated.

Specifically, in the context of the cancer therapeutic process, methodsfor electromagnetic field inductive coupling to biologic tissues areutilized for the purpose of adversely affecting, beyond a tolerance ofnormal biologic homeostasis, the bio-regulatory electric energyinteractions that govern the biologic, biochemical, biophysical andphysiologic processes of cancer cells and cancerous tumor growth andproliferation. Cancer cell growth arrest and apoptosis are the resultsdemonstrated via applying to cancer cells and cancerous tumor tissue theelectromagnetic field energies that are a function of theelectromagnetic signal parameters described in this invention.

Embodiments of the present invention are based on investigations whichdemonstrate an increase in cancer cell and cancerous tumor programmedcell death (apoptosis) as well as an adverse affect on the cancer cellsgrowth and proliferation cycles. These findings are the results ofinductive coupling of electromagnetic field energies of specificfrequencies, waveforms and intensities to cancer cells grown in an invitro setting, as well as cancerous tumor tissues residing in livingmice during in vivo experimental study model trials.

Embodiments of the present invention are intended for use as a means toinduce growth arrest and/or apoptosis in cancer cells and canceroustumors, and adversely affect growth and survival of foreign pathogensthat are either directly associated with the present pathologic cancercondition being treated or potentially serve as a cancer-inducing factorvia the presence of biochemical and physiologic stressors placed uponthe healthy cells and tissues. This therapeutic process is accomplishedvia the external application of electromagnetic field energies ofspecific frequency range, waveform and intensity range to the cancercells, cancerous tumors and/or foreign pathogens. An electromagnetictransducer(s) e.g. coil(s) of any design or configuration that is (are)capable of producing said electromagnetic field energy may be employedas the tool for delivery of the electromagnetic field energy to thetreatment site of interest. Any of a variety of electrical signalgenerators can be used to provide alternating (e.g., sinusoidal, square,sawtooth, etc.) current that can be amplified to the desiredradio-frequency power levels and modulated to give the desired signalcharacteristics such as envelope shapes and repetition rates. Thissignal is used to drive electromagnetic coils with a current that willgenerate a time varying magnetic field, B. The magnetic field penetratesthe biologic tissue and induces an electric field in the tissue.

To optimize the transfer of power from the signal generator and theamplifier into the tissue, a tuner or alike may be used to match theelectrical impedances. The electromagnetic field energy is delivered toa treatment site of a patient by anatomically positioning anelectromagnetic coil or multiple coil assembly on, around, or about theouter skin surface of the patient. The electromagnetic coil assembly ispositioned to deliver the highest quality, in terms ofbio-effectiveness, electromagnetic field energy possible to the area ofthe cancer and or tumor site and/or site of foreign pathogens to betreated.

One aspect of the present invention is to provide a particularlyconfigured electromagnetic field to a treatment site having one or morecancer cells and/or foreign pathogens located, and where theelectromagnetic field either has or is generated by electrical currenthaving a particular waveform, frequency range and field intensity range.Moreover, embodiments of the present invention utilize electromagneticfield signal parameters which include the harmonics and infinitesub-harmonics of any one or more of the particular signal parametersprovided herein, particularly when such parameters have alreadydemonstrated cell growth arrest and apoptosis in cancer cells and livecancerous tumors specifically. The same or similar signal parameterswhich have been found to adversely affect cancer cell growth andproliferation will be applied to infection-associated foreign pathogensthat are directly associated with the present cancer condition beingtreated.

One aspect of the present invention is to provide an electromagneticfield energy delivery to a patient via non-invasive electromagneticfield producing instruments that are capable, by way of inductivecoupling, to deliver the electromagnetic field energies to the targetedcancer cells, tumor tissues and/or foreign pathogens of interest. Theelectromagnetic field signal parameters described herein are intended tobe used specifically as a tool to induce cancer cell growth arrest andapoptosis, and in addition, used to adversely affect the growth,development and survival of foreign pathogens such as any one orcombination of virus, bacterial, fungus, and parasite.

In accordance with at least some embodiments of the present invention,non-invasive methods for the delivery of the electromagnetic fieldenergy to the area of cancer and/or foreign pathogen growth andproliferation in the patient are used. That is to say, theelectromagnetic field energy parameters can be delivered via anyexternally placed electronic device that can serve the purpose ofdelivering the designated signal by means of electromagnetic fieldenergy to the patient during treatment and attain the desired biologiceffect.

In accordance with at least some embodiments the mode of energy transferbetween the electronic device and the patient is electromagneticfield/tissue inductive coupling of energy.

It is also one aspect of the present invention to employ electromagnetictransducer(s) such as a coil(s) type of devices for the purpose ofdelivering electromagnetic field energy via a method of electromagneticfield/tissue inductive coupling to a patient, due to the fact that theelectromagnetic field signal parameters used herein are specificallydesignated to cause growth arrest of cancer cells and or death of cancercells via apoptotic pathways specifically, as well as growth arrest andreduced survival of foreign pathogens.

As can be appreciated by one skilled in the art, the electromagneticfield signal parameter ranges discussed herein are intended for deliveryto a patient via any of the various possible designs of exteriorbody-positioned electromagnetic transducers, e.g. coils, electromagneticfield producing instruments or device systems, capable of deliveringsaid electromagnetic field energies and attaining the desired biologiceffect.

The biological effect to the cancer cells, cancerous tumors, and/orforeign pathogens resulting from application of the electromagneticenergy signal parameters herein are not a result of excessive levels ofheat, radiation, electric current, or high electric voltage that wouldtypically be considered lethal and destructive to cancer cells,cancerous tumors, and/or foreign pathogens, as well as normal cells andnormal tissues. The electromagnetic energy levels described herein causereduced growth and cell death to cancer cells, cancerous tissues, and/orforeign pathogens without causing lethal damage and destruction tonormal cells and tissues.

Other past solutions that use similar electromagnetic field signalparameters for the treatment of cancer describe the use of surgicallyinvasive inserted electrodes made of wire or other materials capable ofelectric conduction.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a first exemplary transducerplaced in a position to treat a treatment site;

FIG. 2 is a schematic representation of a second exemplary transducerplaced in a position to treat a treatment site;

FIG. 3 is a more detailed depiction of an exemplary transducer and itsinteraction with a treatment site;

FIG. 4 is a block diagram depicting a first exemplary treatment system;

FIG. 5 is a block diagram depicting a second exemplary treatment system;

FIG. 6 is a block diagram depicting a third exemplary treatment system;

FIG. 7 is a block diagram depicting a fourth exemplary treatment system;

FIG. 8 is a block diagram depicting a fifth exemplary treatment system;

FIG. 9 is a block diagram depicting a sixth exemplary treatment system;

FIG. 10 is a block diagram depicting a seventh exemplary treatmentsystem;

FIG. 11 depicts an exemplary waveform used for treating cancer and/orforeign pathogens in accordance with at least some embodiments of thepresent invention; and

FIG. 12 depicts an exemplary waveform used for treating cancer and/orforeign pathogens in accordance with at least some embodiments of thepresent invention.

DETAILED DESCRIPTION

Embodiments of the present invention provide an electrotherapeuticsystem of employing electromagnetic field energies to a human or animalfor the purpose of inducing growth arrest and cell death in cancer cellsand cancerous tumors and/or foreign pathogens that reside in the body ofanimals or humans. The electromagnetic fields can be synthesized by anytype of the many varieties of signal generators, signal amplifiers, andgeometrically configured electromagnetic coil designs. For example, withreference to FIGS. 1-3, these diagrams represent three different typesof electromagnetic coil configurations that can be selected and used toapply the signal by means of electromagnetic field for treating cancerand/or foreign pathogens.

The exemplary embodiment depicted in FIG. 1 represents the solenoiddesign type that utilizes wire windings of various circular dimensionsto carry electric current and induce electromagnetic fields. The inducedelectric fields are strongest at the wires and inside the perimeters ofthe coil boundaries where the targeted cancer tissue and/or foreignpathogens can be located during patient treatment.

FIG. 2 depicts another exemplary embodiment where a figure eight designtype is used whereas the wire windings are configured in the shape ofthe number eight and these wire windings carry electrical current usedto induce electromagnetic fields. The induced electric fields aretypically the strongest perpendicular to the center area of the figureeight coil at a point where the windings cross one another and thus itis this area that would be most effective during treatment of acancerous tumor and/or foreign pathogen in a patient.

FIG. 3 depicts another exemplary embodiment where a solid core typedesign is used and is electrically energized via wire wrappings around asolid iron, ferrite, or mixed alloy core. The current induces a magneticfield in the iron core and the magnetic field is transmitted across theopen gap. The induced electric field is substantially oriented at aright angle to the magnetic field and the targeted cancer cells,cancerous tumor tissues and/or foreign pathogens are placed such thatthey are exposed to these fields. The coil depicted in FIG. 3 may beplaced such that the targeted area of interest on the patient would falladjacent or within the gap in the core.

FIGS. 4-6 depict examples of various types of portable coil apparatusesand systems that can be used during treatment application for thedelivery of an electromagnetic field to the patient. In accordance withat least some embodiments of the present invention, the coil apparatusesmay be secured to the patient via a non-conductive means, such as byusing fabric or other non-conductive materials. Alternatively, or inaddition, the coils may be placed on the patient and held in place bygravity. As another alternative, the coils may be secured to the patientwith a preconfigured device that is capable of conducting electricityand generating its own electromagnetic field, which can be used tosupplement or direct the electromagnetic field generated by the primarycoil apparatus.

As an alternative to using portable coils, or in addition to using suchcoils, embodiments of the present invention also contemplate the use ofa stationary coil or set of coils that can be configured to have apatient moved into and about such coils. Such exemplary embodiments aredepicted in FIGS. 7-10 where it is shown that the stationary tabledesign types of coil assemblies can be used for application ofelectromagnetic energy to a patient in the clinical setting, where thepatient is resting on the table during the electromagnetic fielddelivery. More particularly, embodiments of the present invention may beadapted to employ a clam-shell coil configuration (FIG. 7), a full coilconfiguration (FIG. 8), one or two opposing figure eight coils (FIG. 9),and/or a c-shaped coil (FIG. 10). One or more of such exemplaryelectromagnetic energy delivery systems may be described in furtherdetail in one or more of the following patent documents, each of whichare hereby incorporated herein in their entirety: U.S. Pat. Nos.7,160,241; 6,060,293; 5,723,001; 4,998,532; 4,454,882; 5,014,699;4,674,482; 6,208,892; 6,856,839; US 2001/0021868.

The electromagnetic energy field generated by a coil and applied to apatient in accordance with at least some embodiments of the presentinvention is composed of current and voltage (i.e., is generated in acoil or similar conductor at a particular voltage and current level) toinduce a particular magnetic field. The electromagnetic field may besynthesized by one or multiple electrically energized electromagneticcoils that are connected via terminals and cables to an electric signalsource. That is to say, a single coil or multiple coils are driven by asignal source from a suitable or commercially available signal generatorwith an output current that is amplified by a suitable or commerciallyavailable amplifier. The amplified signal is then delivered to a coilwhich can be made of various electric conducting materials (e.g., steel,copper, aluminum, gold, silver, etc.), and that may be configured thesame, similar, or different from the coils referred to FIGS. 1-3, andwhereby the current traveling through the coil material produces amagnetic field.

The magnetic field is adapted to induce an electric field, thus theelectromagnetic field is produced. During treatment applications on apatient, and with a coil assembly as described above positioned on,about, or around the tissue area of choice, the electromagnetic fieldthen inductively couples to the dielectric pathways of the targetedcancer cell, cancerous tissue and/or foreign pathogen of interest,thereby inducing electrical potential in the targeted cancer cell,cancerous tissue, and/or foreign pathogen and inducing the desiredbiophysical event. To optimize the uniformity of the electromagneticfield lines and induced voltage in the targeted cancer cells, canceroustumor tissues, and/or cell/tissue sites of foreign pathogens it isrecommended that the size of the coil that is used for treatment of theabove be determined with consideration to the anatomical location andsize of the treatment site being addressed. Situations can arise whereimpedance miss-match between the coil and tissues can occur as a resultof coil placement on, about or around the body. The coil/tissueinductive coupling event can be optimized to deliver the mostappropriate and required electromagnetic energy via a process ofimpedance-matching. Impedance-matching is made possible with the use ofan impedance-matching transformer and/or impedance matching capacitorthat is typically located between the output of the amplifier and inputof the coil structure. Of course, embodiments of the present disclosureare not limited to the use of an impedance-matching transformed.Instead, it should be appreciated that one or more capacitors can beused alone or in combination with one or more transformers to produceand apply the desired output signal.

One of the embodiments of this invention includes a signal comprisingmodulated-bursts of a sine wave (or similar type of wave), and thiselectromagnetic energy is delivered to the area of cancer and/or foreignpathogen growth at a pre-determined amplitude range. The amplitude ofthe electromagnetic wave is set by controlling the current output fromthe current source to the amplifier. In the context of cancer, theelectromagnetic signal parameters found to be effective in reducingcancer cell proliferation and inducing cancer cell apoptosis are withina particular range. The biology and physiology of cancer and that offoreign pathogens are diverse, such that cancer cells, cancerous tumorsand foreign pathogens demonstrate a wide heterogeneous biologic andphysiologic nature. In addition, it is recognized scientifically thatwidespread histological diversities exist among the various anatomicalregions in the body where cancer cells and/or foreign pathogens mayreside. Therefore, the electromagnetic field signal parameters that canbe selected to optimally treat a cancer cell, cancerous tissue and/orone or more foreign pathogens, but not harm normal cells include, butare not limited to, waveform, peak field strength, carrier frequency,duty cycle, burst duration time, rise and/or fall times, and burstrepetition rate. The particular combination of values for each parametermay vary across a certain range depending upon the histologicdiversities of various anatomical treatment sites, as well asdiversities of certain biologic factors. These biologic factors include,but are not limited to, specific cancer cell or foreign pathogengenotype, phenotype, cell sensitivity to environment, and variableswithin the biologic, physiologic, biophysical and biochemical propertiesof the specific cancer cells, cancerous tissues and/or foreign pathogensbeing treated. The absorption of the signal by the biologic entity beingtreated occurs over a range of frequencies so that it is expected therewill be a range for frequencies corresponding to the line width of theabsorption spectra of the biologic processes within that biologic entitybeing excited or activated by the applied signal. Accordingly, theimpedance matching transformer and/or capacitor may be employed and mayhave as an input to its control mechanism one or more sensors connectedto the patient that are adapted to measure one or more of the biologicfactors of interest.

The variation of electromagnetic field signal properties within theelectromagnetic field signal parameter range that are necessary toaddress the above histological and biologic factors includes, but is notlimited to, waveform type, carrier frequency, burst duration and width,duty cycle, burst repetition rate, rise and/or fall time, and peakamplitude. These electromagnetic field signal parameters are expected torange over the bandwidth of the response time for the biologic tissuebeing addressed in order to demonstrate effectiveness in terms of cancercell growth arrest, induction of cancer cell apoptosis, and/or foreignpathogen growth arrest. The electromagnetic field signal parametersfound to be effective for cancer cell growth arrest and apoptosisinduction are multiple signal components to include any Fouriercomponents within the spectral parameters of the pulsed-modulated burstsof sinusoidal bipolar radio-frequencies described in this invention.

As can be appreciated by one skilled in the art, electromagnetic fieldsignal parameters used can be inclusive within the parameters or rangeof parameters discussed herein for use relative to the treatment ofcancer, cancerous tumors and/or foreign pathogens in animals or humans.

As one example, and as can be seen in FIG. 11, about a 100 kHz to about1 GHz bipolar sinusoidal waveform, or preferably a 1 MHz to 100 MHzbipolar sinusoidal waveform, or more preferably about a 27 MHz bipolarsinusoidal waveform (where the frequency of the waveform is maintainedlow enough to avoid excessive tissue heating), when properly gaitedusing a signal control unit, and when delivered to the tissue site ofinterest as a pulse modulated burst width of less than 3 microsecondsand more specifically between about 0.2 microseconds and about 20microseconds, or preferably between about 1 microsecond and about 10microseconds, or more preferably about 2 microseconds duration, (54cycles/burst) and at a burst repetition rate of between about 100 and300 kHz, or preferably between about 150 kHz and 250 kHz, or morepreferably about 200 kHz has demonstrated successful biologicaleffectiveness in the context of arresting cancer cell growth andproliferation, and inducing cancer cell apoptosis in cancerous tumors ofliving mice. This particular waveform may be applied with any of thecoil devices or system described herein. For instance, any suitableportable or stationary electromagnetic coil device or electric fieldproducing device thereof, capable of delivering the electromagneticenergy signal to the cancerous tumor site, and/or site of foreignpathogen growth and within the guidelines, parameters, andspecifications as described in this invention, can be employed.

As another example, and as can be seen in FIG. 12, about a 100 kHz toabout 1 GHz bipolar sinusoidal waveform, or preferably a 1 MHz to 100MHz bipolar sinusoidal waveform, or more preferably about a 27 MHzbipolar sinusoidal waveform that is properly gaited by using a signalcontrol unit, and when delivered to the tissue site of interest as apulse modulated burst width of between about 0.015 milliseconds andabout 150 milliseconds, or preferably between about 0.15 millisecondsand about 15 milliseconds, or more preferably about 1.5 millisecondsduration, (15,000 cycles/burst), and a burst repetition rate of betweenabout 0.15 Hz and about 1.5 kHz, or preferably between about 0.5 Hz andabout 20 Hz, or more preferably about 15 Hz has demonstrated successfulbiologic effectiveness in the context of cancer cell growth arrest andapoptosis induction in cancerous tumors of living mice. This particularwaveform may be applied with any of the coil devices or system describedherein. For instance, any suitable portable or stationaryelectromagnetic coil device or electric field producing device thereof,capable of delivering the electromagnetic energy signal to the canceroustumor site and/or site of foreign pathogen growth, and within theguidelines, parameters, and specifications as described in thisinvention, can be employed.

The solid ferrite type of coil or other metal alloy types may be used tooptimize certain frequencies used in this invention, thereby helping toreduce the power required to drive this coil. The electromagnetic fieldpeak amplitude levels for both of the pulse-modulated radio-frequencyburst signals described above that demonstrate decreased cancer cellgrowth, proliferation, and apoptosis, when applied to cancer cells ortumors during the time points and vulnerable cell cycle periods asdescribed below, are in a range of about 1 to 300 V/cm, or peakamplitudes that are less than that which causes significant or sustaineddamage to (most) normal cells or tissues. More specifically, embodimentsof the present invention contemplate that some damage may occur to somenormal cells around a targeted region of cancer cells, but such damageshould be limited in terms of the size and scope (e.g., if a tumor isbeing treated in a liver or similar internal organ, then some healthytissues in the internal organ and surrounding areas may be damaged, butthe extent of such damage should be limited by properly controlling thecharacteristics of the electromagnetic field). The current density ofthese fields would be in the range of several amps per meter squared,and this value is dependent on the tissue impedance being targeted andexposed during patient treatment.

In the context of the cancerous tumor and/or foreign pathogenenvironment the growth and division regulatory cell cycles of cancercells, cancerous tumor tissue and of foreign pathogens typically are notcollectively synchronized with one another. In terms of cell sensitivityto the electromagnetic field energies, many of the diverse cancer cellgenotypes and or phenotypes that make up the tumor proper haveindividual critical points in their growth and division cell cycles as afunction of biological timing and molecular vulnerability. It istherefore clarified that in order to attain success in arresting cancercell growth and/or inducing cancer cell or cancerous tumor cellapoptosis, the electromagnetic field energies described herein and usedin accordance with at least some embodiments of the present inventionshould be presented and/or delivered to any tumor cell of therapeutictreatment interest during at least one or more critical cell cyclebiological time points or molecular vulnerability points or relevantlysensitive points within that given tumor cell. This same principleshould be applied when treating foreign pathogens with electromagneticenergies.

The final effect from the electromagnetic field energies delivered tothe area of cancer is inhibition of the cancer cells growth cycle,decreased cancer cell growth rate, and cancer cell apoptosis. It hasbeen determined that the outcomes of applying electromagnetic fieldsignals to cancer growth in tumors residing in living mice that theabove electromagnetic signal parameters are effective in retardingcancer cell growth and inducing cancer cell apoptosis.

While embodiments of the present invention have been described inconnection with the treatment of cancer, it is well recognized thatforeign pathogens to include virus, bacteria, fungus and parasitesrepresent a wide diversity in their biologic and physiologiccharacteristics, therefore it is expected that the electromagneticsignal parameters found to be effective in the context of cancer cellgrowth inhibition can differ in terms of demonstrating effectiveness foradversely affecting growth and survival of the above foreign pathogens.That is to say, certain foreign pathogens have evolved as such withextraordinary capabilities to survive and proliferate under what wouldbe considered in a healthy biologic context, as sub-optimal growthconditions. Often times these pathogens demonstrate increased tolerancesto biologic stressors, which in a biologic context could or would beconsidered harmful to normal cells and tissues. Therefore, it isexpected that the electromagnetic signal parameters found to beeffective for the treatment of cancer will require adjustment for thetreatment each individual foreign pathogen, however, keeping within theelectromagnetic signal parameter ranges described in this patent.

EXAMPLE 1

To insure adequate tumor development the immuno-compromised mouse strainICR-scid was chosen for these experiments. Four male mice were injectedwith a human pancreatic cancer cell line for the purpose of inducingtumor development. Ample time was allowed for tumor development in eachmouse. Two mice were used for electromagnetic field exposure applicationand two were used as a non-exposed control group.

Three different coil configurations as shown in FIGS. 1-3 wereindividually tested as part of this study. Individual coils were applieddirectly over the tumor site of the mouse in a manner that allowed forinductive coupling of the electromagnetic field signal into the area ofthe mouse tumor. The two mice were exposed individually throughout allperiods of the tumor growth cycle. The electromagnetic signal parametersdescribed in the detail section of this invention were applied for eachindividual mouse that was exposed. The tumors of all four mice weresurgically removed five days after the finish of the last exposureapplication and preserved in formalin. Each individual tumor was thensectioned into three individual areas and the tumor tissues processedand mounted on glass slides for histo-chemical study. The tissues of thetumor samples were stained using TUNEL staining which is one of thecurrent standards for detection of apoptosis. The slides were read usingfluorescence microscopy and six photographs of each tissue section wereacquired. The TUNEL staining was quantified in the following manner. Allimages were acquired with the same exposure and gain settings. For eachfield, the total TUNEL fluorescence per nucleus was quantified. Nucleiwere defined by thresholding the DAPI signal. The threshold image wasused as a mask on the TUNEL image to define nuclear TUNEL labeling. Themasked TUNEL image was thresholded and the integrated intensity wascalculated. Nuclei were counted manually in each field using DAPIlabeling. Total apoptotic activity was calculated as nuclear TUNELintegrated intensity.

Experiment results demonstrate a substantial increase of up to and above50% in the level of apoptotic related cell death in the electromagneticfield exposed mouse group when compared to the unexposed mouse controlgroup when using certain exposure parameters, numerical differences interms of the level of cell apoptotic activity vary between the twoexposed mice on an individual basis, and there is a numerical variationof cell apoptosis measured among individual tissue sectionscorresponding to anatomical depth within the same tumor. This mostlikely reflects electromagnetic field differences in terms of fieldamplitude relative to distance from various sections of the tumor. Thisexperiment was repeated with similar results.

EXAMPLE 2

Another example demonstrated in accordance with embodiments of thepresent disclosure employs one or more of the above-described signals,but introduces an interruption or interruption pattern. Specifically,various combinations of the above-described signals have been testedwhereby during the treatment process, the signal was interrupted ordiscontinued for a predetermined or random amount of time. It has beensuggested, based on therapeutic strategies related to tissueregeneration, that if cancerous cells are exposed to a particular typeof treatment signal for a prolonged amount of time, then some times thecancerous cells may have the ability to adapt to overcome the treatmentsignal. Accordingly, one non-limiting example of the present disclosureutilizes a signal as described above, but the signal is turned on andoff for predetermined amounts of time. This interruption of the signal(e.g., of the treatment via the signal) may disrupt the cancerous cell'sability to adapt to overcome the treatment signal.

In some embodiments, the interruption can be introduced on a somewhatregular or periodic basis. In some embodiments, the interruption can beintroduced on an irregular or random basis.

EXAMPLE 3

Another example considered in accordance with embodiments of the presentdisclosure may utilize two different signals. Each of the signals can begenerated and applied as described above, but having at least one of thefollowing parameters different from each other: pulse rate; pulseduration; current modulation; wave type; peak amplitude; and frequency.A first of the two signals can be applied at various intervals during anapplication period and a second of the two signals can be applied atdifferent intervals during the same application period. Some times, boththe first and second signals can be on. At other times during theapplication period, both the first and second signals can be off. Atstill other times during the application period, only one of the firstand second signals may be on. As with the single signal of Example 2, itshould be appreciated that the intervals during which the first andsecond signals applied may vary on a periodic, random, or semi-randombasis. By using two different signals, the confusion introduced by thevariable application of the signals can be increased. Accordingly, thecancerous cells may have an even more difficult time adapting to thetreatment signals.

It should be appreciated that while only two different signals have beendescribed in this particular example, embodiments of the presentdisclosure are not so limited. Specifically, embodiments of the presentdisclosure may include the variable application of three, four, five, .. . , ten, twenty, or more different signals, where each of the signalshas at least one parameter that is different from the others of thesignals.

While embodiments of the present invention have been described inconnection with particular apparatuses, methods, systems, and systemcomponents, the invention is not so limited. Moreover, one skilled inthe art will appreciate that each feature of the present inventiondescribed herein may be separately claimable. Furthermore, embodimentsof the present invention are not necessarily limited to the treatment ofcancerous cells, although experimental data has been produced showingpositive results when used on such cells. Rather, embodiments of thepresent invention may also be used to target any particular type of cellor foreign pathogen (whether cancerous or not) based on itscharacteristics and to impart a particular reaction from that cell orgroup of cells having the common characteristic. The reaction impartedmay be controlled by intelligently adjusting the parameters of theelectromagnetic field applied thereto.

What is claimed is:
 1. An apparatus, comprising: a transducer adapted toconduct current; a current generator adapted to induce a current flow inthe transducer; and wherein the transducer is located proximate to atreatment site, the treatment site comprising a combination of: (i)healthy cells and (ii) one or more of a foreign pathogen and cancercells, such that when current flow is induced in the transducer anelectromagnetic field is produced that induces growth arrest and/orapoptosis in one or more of the foreign pathogens and the cancer cellsby generating an electromagnetic field that comprises a peak amplitudegreater than 100 V/cm.
 2. The apparatus of claim 1, wherein thetransducer comprises a coil winding and wherein the current generatorgenerates about a 27 MHz bipolar sinusoidal current.
 3. The apparatus ofclaim 2, wherein the current is pulsed for a predetermined duration at apredetermined pulse rate.
 4. The apparatus of claim 3, wherein thepredetermined pulse duration is between about 1 and 3 microseconds induration.
 5. The apparatus of claim 1, wherein the treatment sitecomprises the foreign pathogen and wherein the foreign pathogencomprises one or more of bacteria, a virus, a fungus, and a parasite. 6.The apparatus of claim 1, wherein the electromagnetic field isintermittently turned on and off over the course of a treatment period.7. The apparatus of claim 6, wherein the electromagnetic field isintermittently turned on and off on a periodic basis during thetreatment period.
 8. The apparatus of claim 6, wherein theelectromagnetic field is intermittently turned on and off on a randombasis during the treatment period.
 9. The apparatus of claim 1, whereinthe transducer comprises at least one of an impedance matchingtransformer and an impedance matching capacitor.
 10. The apparatus ofclaim 1, wherein the electromagnetic signal comprises an originalsignal, Fourier components of the original signal, and signal componentsthat are generated by nonlinearities of biologic tissue as a result ofapplication of the original signal to the biologic tissue beingaddressed.
 11. The apparatus of claim 1, wherein the transducercorresponds to a first transducer, the apparatus further comprising asecond transducer configured to generate a second electromagnetic fieldhaving at least one property that is different from the electromagneticfield generated by the first transducer.
 12. The apparatus of claim 1,wherein the pulse width of the electromagnetic signal is varied between1 microsecond and 3 microseconds on a random basis.
 13. A method oftreating at least one of a cancer cell and foreign pathogen in atreatment site, the method comprising: generating a first current;modulating the first current at a predetermined frequency that isgreater than approximately 10 MHz; pulsing the first current for apredetermined pulse duration that is less than about 3.0 microseconds induration; repeating the generation of the pulsed first current at arepetition rate that is between about 0.5 Hz and about 20 Hz; providingthe repeatedly-generated pulsed first currents to a first conductiveelement, wherein the first conductive element generates anelectromagnetic field when the first currents are applied thereto, theelectromagnetic field being adapted to treat the at least one of acancer cell and foreign pathogen in the treatment site.
 14. The methodof claim 13, wherein the repetition rate is varied on a random basis.15. The method of claim 14, wherein the repetition rate is variedbetween 0.5 Hz and 20Hz during a treatment period.
 16. The method ofclaim 15, wherein the first current is intermittently interrupted on aperiodic basis during the treatment period.
 17. The method of claim 15,wherein the first current is intermittently interrupted on a randombasis during the treatment period.
 18. The method of claim 14, whereinthe repetition rate is about 2 Hz.
 19. The method of claim 13, whereinthe predetermined frequency is about 27 MHz.
 20. The method of claim 13,wherein the first conductive element comprises at least one of acapacitor and a transformer.